BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM CUP

    MDR report key: 1842753 · Received September 10, 2010

    Report

    Report Number
    9613350-2010-00423
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    September 15, 2009
    Report Date
    September 15, 2009
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER (B)(4), WHICH MARKETS THE DEVICES IN THE (B)(6). THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN 07/2008. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE (S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE (B)(4) CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT RECEIVED A HIP IMPLANT ON AN UNK DATE. DUE TO LOOSENING OF THE DUROM ACETABULAR COMPONENT REVISION SURGERY TOOK PLACE ON AN UNK DATE. DATE OF IMPLANT: UNK. TIME IN-VIVO: UNK. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM CUP DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization